Interest of Urinary Oxygen Partial Pressure (PO2u) in Predicting the Onset or Recovery of Acute Renal Failure During Shock States - OXYpi Study (OXYpi)

Shock state is defined as an acute, life-threatening, circulatory failure with impaired tissue oxygenation (or tissue hypoxia). The cause of the shock state can be septic, anaphylactic, hypovolemic or cardiogenic. Its management is based on etiological treatment and replacement of organ failures. Acute kidney injury (AKI) may be lead by renal hypoxia. Acute kidney injury is frequent in patients admitted to intensive care unit (ICU) and associated with an increased mortality. Serum creatinine is the reference biological marker in the diagnosis of Acute kidney injury. However, its use is limited by a delayed increase in plasma creatinine level in relation to the causal renal agression, at a time when renal tissue damage may already be established. Thus, the identification of a biological marker making it possible to estimate renal hypoxia continuously during a shock could allow us to identify early a situation at risk of evolving into Acute kidney injury.

The renal medulla is vulnerable to tissue hypoxia with a risk of acute tubular necrosis. As in situ measurement of mPO2 is not possible in current practice in humans, several studies have shown a positive correlation between variations in mPO2/uPO2 and occurence of Acute kidney injury. In humans, studies have shown a significant association between the reduction in uPO2 in cardiac surgeries and the occurrence of postoperative Acute kidney injury. The aim of the study is to describe the association between uPO2 values and the onset of Acute kidney injury and/or the ocurrence of early recovery of renal function after Acute kidney injury. Any patient in shock (group A) or without shock and requiring urinary catheterization as part of treatment (group B) admitted to the Medical-Intensive Care Unit of Angers University Hospital is eligible for inclusion. After inclusion, a continuous uPO2 measuring probe is introduced with the placement of the urinary probe. uPO2 is collected continuously for the first 5 days of admission or until discharge from intensive care or removal of the urinary catheter. uPO2 is also measured by a gasometry on a urine sample on a multi-daily basis. Serum creatinine is collected every 12 hours (twice a day) and diuresis every two hours for 5 days.

Study Overview

• Status: Recruiting
• Conditions: Shock Circulatory
• Intervention / Treatment: Biological: Continuous measurement of uPO2 (both groups)

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas FAGE, PhD; Phone Number: +33 2 41 35 58 65; Email: nicolas.fage@chu-angers.fr
• Study Contact Backup: Name: DRCI CHU Angers Promotion Internea; Phone Number: +33 2 41 35 36 37; Email: DRCI-promotion-interne@chu-angers.fr

Study Locations

• France
  • Angers, France, 49933
    • Recruiting
    • University hospital of Angers
    • Contact: Nicolas Fage, PhD
  • Le Kremlin-Bicêtre, France
    • Not yet recruiting
    • Bicetre Hospital
    • Contact: Xavier Monnet; Email: xavier.monnet@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria :

Group A:

- Patient admitted to Intensive Care Unit with a shock state defined by arterial hypotension requiring vascular filling and/or introduction of catecholamines - Age ≥ 18 years - Affiliated or benificiary of a social security scheme - Consent of the patient or a relative, or inclusion as part of an emergency inclusion procedure

Group B:

• Patient admitted to Intensive Care Unit without shock
• Requiring urinary catheterization as part of routine care
• Age ≥ 18 years
• Affiliated or benificiary of a social security scheme
• Consent of the patient or a relative, or inclusion as part of an emergency inclusion procedure

Exclusion Criteria:

- Preexisting chronic kidney disease (CKD) (GFR < 60 mL/min/1,73 m2 according to MDRD) - Chronic dialysis and/or kidney transplant - Anuria - Indication for renal replacement therapy (life-threatening hyperkaliemia, severe metabolic acidosis pH < 7,15, uremia > 40 mmol/L, pulmonary edema resistant to diuretics) - Patient requiring an extracorporeal life support (ECLS) - Pregnant, breastfeeding or parturient woman - Patient deprived of liberty by judicial or administrative decision - Patient under psychiatric care - Patient under legal protection measures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Shock population; Insertion of bladder urine probe (Oxylite Pro ® device) and assessment of continuous uPO2	Biological: Continuous measurement of uPO2 (both groups); uPO2 is collected continuously for the first 5 days of admission or until discharge from intensive care or removal of the urinary catheter.
Other: Without Shock Population; Insertion of bladder urine probe (Oxylite Pro ® device) and assessment of continuous uPO2	Biological: Continuous measurement of uPO2 (both groups); uPO2 is collected continuously for the first 5 days of admission or until discharge from intensive care or removal of the urinary catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A - For patients without acute kidney injury at inclusion, the occurence of acute kidney injury and its severity according to the KDIGO criteria	A KDIGO Criteria: Increase in serum creatinine ≥ 26.5 µmol/L during the 48 hours following inclusion Or an increase of ≥ 1.5 fold the admission serum creatinine during the first 5 days Or Diuresis < 0.5 mL/kg/h for 6 hours during the first 5 days	During the first 5 days after inclusion.
B - For patients with acute kidney injury occurring during the first 3 days following inclusion, early recovery is defined by the return to pre-shock renal function 48 hours from the start of acute kidney injury	A KDIGO Criteria: Increase in serum creatinine ≥ 26.5 µmol/L during the 48 hours following inclusion Or an increase of ≥ 1.5 fold the admission serum creatinine during the first 5 days Or Diuresis < 0.5 mL/kg/h for 6 hours during the first 5 days	During the first 5 days after inclusion.
C - For patients with acute kidney injury occurring at inclusion, describe the evolution of PO2u values in patients with worsening renal function	A KDIGO Criteria: Increase in serum creatinine ≥ 26.5 µmol/L during the 48 hours following inclusion Or an increase of ≥ 1.5 fold the admission serum creatinine during the first 5 days Or Diuresis < 0.5 mL/kg/h for 6 hours during the first 5 days	During the first 5 days after inclusion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In patients in group A, assess the association between uPO2 variation and acute kidney injury, defined by KDIGO criteria, in different subgroups (septic shock, sepsis without norepinephrine, non-septic shock).	KDIGO Criteria: Increase in serum creatinine ≥ 26.5 µmol/L during the 48 hours following inclusion Or an increase of ≥ 1.5 fold the admission serum creatinine during the first 5 days Or Diuresis < 0.5 mL/kg/h for 6 hours during the first 5 days. Sepsis is defined as a life-threatening organ dysfunction caused by suspected or confirmed infection. Septic shock is defined as a sepsis with need of norepinephrine.	During the first 5 days after inclusion.
In patients in group A with newly occured acute kidney injury, assess the association between uPO2 variation and recovery of acute kidney injury in different subgroups (septic shock, sepsis without norepinephrine, non-septic shock).	For patients with acute kidney injury occurring during the first 3 days following inclusion, early recovery is defined by the return to pre-shock renal function 48 hours from the start of acute kidney injury. Sepsis is defined as a life-threatening organ dysfunction caused by suspected or confirmed infection. Septic shock is defined as a sepsis with need of norepinephrine.	During the first 5 days after inclusion.
In patients in group A, assess the evolution of uPO2 during the first 5 days in patients with and without sepsis	uPO2 is collected continuously for the first 5 days of admission or until discharge from intensive care or removal of the urinary catheter.	During the first 5 days after inclusion or until discharge from intensive care or removal of the urinary catheter.
Describe the variation of uPO2 according to evolution of Mean Arterial Pressure and cardiac output in the subgroup of patients who received fluid expansion	uPO2 is collected continuously for the first 5 days of admission or until discharge from intensive care or removal of the urinary catheter. Mean Arterial Pressure is measured continuously with an in situ arterial line and cardiac output is measured invasively by transpulmonary thermodilution or a pulmonary arterial catheterization, or non-invasively by transthoraci echocardiography	During the first 5 days after inclusion or until discharge from intensive care or removal of the urinary catheter.
Describe the variation of uPO2 according to evolution of Mean Arterial Pressure and cardiac output in the subgroup of patients who received blood transfusion	uPO2 is collected continuously for the first 5 days of admission or until discharge from intensive care or removal of the urinary catheter. Mean Arterial Pressure is measured continuously with an in situ arterial line and cardiac output is measured invasively by transpulmonary thermodilution or a pulmonary arterial catheterization, or non-invasively by transthoracic echocardiography	During the first 5 days after inclusion or until discharge from intensive care or removal of the urinary catheter.
In patients with need of increasing Mean Arterial Pressure by increase of norepinephrine doses, describe the evolution of uPO2 according to Mean Arterial Pressure evolution.	uPO2 is collected continuously for the first 5 days of admission or until discharge from intensive care or removal of the urinary catheter. Mean Arterial Pressure is measured continuously with an in situ arterial line.	During 1 hour from the beginning of the increase of norepinephrine doses.
In patients with need of introduction or increase of dobutamine, describe the evolution of uPO2 according to cardiac output or Mean Arterial Pressure evolution.	uPO2 is collected continuously for the first 5 days of admission or until discharge from intensive care or removal of the urinary catheter. Mean Arterial Pressure is measured continuously with an in situ arterial line and cardiac output is measured invasively by transpulmonary thermodilution or a pulmonary arterial catheterization, or non-invasively by transthoraci echocardiography	During 1 hour from the introduction or increase of dobutamine.
Evaluation the correlation between uPO2 assessed by Oxylite Pro® device and urinary gasometry.	Evaluation the correlation between uPO2 assessed by Oxylite Pro® device and urinary gasometry.	During the first 5 days after inclusion or until discharge from intensive care or removal of the urinary catheter.
In patients without shock, describe the evolution of uPO2 during the first 5 days.	uPO2 is collected continuously for the first 5 days of admission or until discharge from intensive care or removal of the urinary catheter.	During the first 5 days after inclusion or until discharge from intensive care or removal of the urinary catheter.
In patients with septic shock, build up a biocollection, enabling further analyses to be carried out at a later date	Build up a biocollection by taking additional blood and urine samples	During the first 5 days after inclusion or until discharge from intensive care or removal of the urinary catheter.
In patients who, during their treatment, have an indication for the introduction or increase of vasopressin: assess the impact of introducing/increasing vasopressin on PO2u.		During 20 minutes from the beginning of the increase of vasopressine doses
For patients whose skin recoloration time and PO2u are assessed before and after a procedure, describe the correlation between changes in PO2u and skin recoloration time during each procedure		During 1 hour from the beginning of the increase of norepinephrine doses, during 1 hour from the introduction or increase of dobutamine, during 20 minutes from the beginning of the increase of vasopressine doses

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2024
• Primary Completion (Estimated): October 18, 2027
• Study Completion (Estimated): January 18, 2028

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Shock; Acute kidney injury; Circulatory failure; Continuous urine oxygen tension
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Acute Kidney Injury; Shock
• Other Study ID Numbers: 49RC23_0417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No